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FDA 510(k) Application Details - K984575
Device Classification Name
Accessories, Soft Lens Products
More FDA Info for this Device
510(K) Number
K984575
Device Name
Accessories, Soft Lens Products
Applicant
ALCON LABORATORIES
6201 SOUTH FREEWAY
R7-14
FORT WORTH, TX 76134-2099 US
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Contact
RALPH H LARSEN
Other 510(k) Applications for this Contact
Regulation Number
886.5928
More FDA Info for this Regulation Number
Classification Product Code
LPN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/23/1998
Decision Date
01/14/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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